DE69732677T2 - Asymmetrical hip stem - Google Patents

Asymmetrical hip stem

Info

Publication number
DE69732677T2
DE69732677T2 DE1997632677 DE69732677T DE69732677T2 DE 69732677 T2 DE69732677 T2 DE 69732677T2 DE 1997632677 DE1997632677 DE 1997632677 DE 69732677 T DE69732677 T DE 69732677T DE 69732677 T2 DE69732677 T2 DE 69732677T2
Authority
DE
Germany
Prior art keywords
shaft
distal
region
axis
lateral
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
DE1997632677
Other languages
German (de)
Other versions
DE69732677D1 (en
Inventor
Anthony K. Hedley
William J. Kelly
Philip C. Noble
Michael J. Schulzki
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Howmedica Osteonics Corp
Original Assignee
Howmedica Osteonics Corp
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Priority to US653295 priority Critical
Priority to US08/653,295 priority patent/US5776204A/en
Application filed by Howmedica Osteonics Corp filed Critical Howmedica Osteonics Corp
Application granted granted Critical
Publication of DE69732677T2 publication Critical patent/DE69732677T2/en
Anticipated expiration legal-status Critical
Application status is Expired - Lifetime legal-status Critical

Links

Classifications

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    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
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    • A61F2220/0025Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
    • A61F2220/0033Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
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    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0018Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in elasticity, stiffness or compressibility
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    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0029Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in bending or flexure capacity
    • AHUMAN NECESSITIES
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    • A61F2250/0058Additional features; Implant or prostheses properties not otherwise provided for
    • A61F2250/0084Means for distinguishing between left-sided and right-sided devices; Sets comprising both left-sided and right-sided prosthetic parts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00029Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium

Description

  • The The present invention relates to femoral hip prostheses and more particularly to a Oberschenkelhüftschaftkomponente with a shape that fits better in the femoral canal.
  • I. Background of the invention
  • Hüftarthroplastikverfahren include implantation of a prosthetic stem component into a femoral intramural canal. A ball at the proximal end of the shaft acts together with a pan of an acetabulum in order for the articulation between thigh or femur and acetabulum too to care. To painless articulation of the hip joint after implantation of the shaft, it is important that the shaft safely in the intramedullary canal is attached. Such attachment can be achieved with bone cement which adheres to the shaft and the wall of the Intramedullärkanals. Furthermore were numerous shafts with a porous one surface as disclosed in U.S. Patent Nos. 4,550,448 (Kenna) and U.S. Pat 3,605,123 (Hahn) taught either for adhesion to the bone cement or the interference fit between the porous surface and the wall of the intramedullary canal to improve. If an interference fit with the intramedullary canal is desired, the shaft contour should closely match the contour of the intramedullary canal, so that the porous Surface in intimate contact with the bone, thereby allowing bone to enter the porous one surface grows.
  • Various Patents relate to a femoral component for press-fitting with and biological fixation in the wall of the proximal metaphyseal and intramedullary canal. U.S. Patent Nos. 4,589,883 (Kenna) and 4,738,681 (Koeneman et al.) teach a femoral stem with a twist in the proximal Region for improved fit and stability in the femoral canal. While this the geometry of the natural Thighs seems to come close, in practice, the rotational movement of the shaft, which is induced by the rotation, to an increase in the Implantation site and lead to the formation of gaps at the implant / bone interface. The Twisting in this area also prevents the shank in the Neck of the thigh is sitting. Instead, the shaft sits in the bone in a rotated position, which makes the preparation of the implantation site more difficult As surgeons often try, the rotational position of the implant to change, to restore the normal position of the femoral head.
  • A second restriction, in the prior art is the cross-sectional shape of the shaft, in particular in the proximal areas of the shaft, wherein the Geometry often involves the removal of strong or hard bone within of the thigh (for example, the calcar femoral and the middle Margin of the greater trochanter) before the stem is implanted correctly can be to achieve a precise fit in the channel. In the Practice this is difficult to achieve with existing surgical Instruments, therefore, it is difficult to such prostheses without reduction or implant missing adjustment. The general document U.S. Patent No. 5,358,534 (Dudasek et al.) As well as the one described above Kenna teach a shaft in which a transverse cross-section, which is taken in the proximal area of the shaft, essentially is rectangular (i.e., has parallel front and back edges). Such a shape does not agree well with the internal anatomy of the femoral intramedullary canal and requires the removal of bone from the greater trochanter during the Implantation. While the Dudasek shaft reveals the presence of a back hollow, to clarify the posterior cortex of the intramedullary canal, teaches he as well not the geometry or the dimensions of the excavation or beats before, for the medullary cavity or Mark cave maximum filled with the shaft can be without the need to remove the calcar femoral.
  • U.S. Patent No. 4,813,963 (Hori et al.) Is directed to a shaft having a configuration which, as described, more particularly reflects the anatomical contours of the intramedullary canal. In particular, the patent teaches a stem in which the proximal portion has an asymmetrical contour in transverse cross section to define a forward side that forms an acute angle with a lateral side and a posterior side approximating the anterior side in the middle direction , The medial side is also curved, while the other sides have linear edges. However, this shaft still requires the removal of bones from the greater trochanter due to the wide angle of the anterior / lateral edge and mass in the posterior / lateral corner. Although developers of previous prosthetic devices have used simple cross-sectional shapes with flat sides to facilitate the fabrication of these implants, the internal contours of the femur are curved and barely linear. As a result shafts, as described by Hori et al. taught, only contact with the femoral cavity at single points, typically along relatively sharp edges. This can lead to a localized stem concentration and could lead to an increased incidence of bone fracture during implantation. In addition, areas of relatively soft bone remain between localized points of contact. These areas tend to become osteoporotic over time, resulting in less biological attachment of the prosthesis through ingrowth of bone. These areas may also act as open channels within the bone structure, rendering the femur susceptible to infiltrating particles created by abrasion of the artificial joint. The biological response to such particles very often results in the erosion of bone around the prosthesis and can cause loosening and failure of the implant.
  • One third problem with the prior art is a pain in the thigh, which often adjusts to a cementless total hip arthroplasty. This Pain is common associated with the stiffness offset between bone and prosthesis. The provision of a distal slot reduces bending stiffness, which reduces subsequent thigh pain. Other useful Effects in reducing distal bending stiffness include easier insertion of the shaft, less occurrence of distal fractures during the Insertion of the stem and easier implantation of the implant with the correct size. Usual slotted Prostheses such as those of Thongpreda et al. (EP-A 0 543 099) and Noiles (U.S. Patent No. 3,996,625) have slots in the apex plane are oriented and therefore only the previous advantages in one Deliver level of bowing. In most activities is the force acting on the distal shaft, not anterior or directed posteriorly, but has a significant medial-lateral Component.
  • II. Summary of the invention
  • in the Light of the prior art problems with femoral hip stems of the prior art, the for cementless hip arthroplasty procedure developed, it is an object of the present invention, to provide stability of the implant / bone interface, to forces to be resisted, which are exerted on the femoral head, by optimizing the fit between the femoral cortex and the surface of the implant becomes. Specifically, it is an object of the present invention to provide an implant having a surface that is profiled that they are the bark walls of the femur (a) anteriorly and posteriorly at the level of femoral neck osteotomy; (b) anterior and medial at the level of the minor and minor trochanter (c) adjusts anteriorly, posteriorly, and laterally in the femoral central.
  • A Another object of the present invention is a femoral implant To provide that is profiled so that a minimum distance of bones during implantation possible especially bones of the greater trochanter and calcar femoral.
  • A Another object of the present invention is the insertion of the implant in the femur maximally, without undersized and bad Alignment.
  • A Another object of the present invention is to increase the magnification of implant wrapping while to minimize the insertion of the shaft.
  • Finally exists Another object of the invention is the flexural stiffness of Minimize shafts in both the sagittal and the apex planes, which reduces the incidence of thigh pain, which allows easier insertion of the shaft and the occurrence of distal Fractures during the insertion of the shaft is reduced.
  • These and further objects of the present invention are achieved by: provided a femoral component for use in hip arthroplasty procedures which is designed so that it fits exactly to the anatomical Outline of the femoral intramedullary canal adapts with minimal bone removal. In particular, the present Invention on a femoral hip stem prosthesis directed as claimed in claim 1.
  • Of the proximal cross-section closes preferably a substantially curved posterior / lateral corner a, which is arranged so that the distance from the surface of Femoral component to the distal longitudinal axis always exceeds a minimum distance, where the distance is greater than or equal is the diameter of the drive shaft of a rigid drilling or extension drill that can be used to edit the medullary canal.
  • Certain Aspects of the present invention further include two adjacent ones geometric bodies a, a femoral neck segment and a medullary segment that like it best shown in transverse sections of the proximal region is oriented at an acute angle to each other.
  • The The present invention is also related to a femoral stem with a directed at the posterior cavity, which is arranged in the proximal region of the shaft, wherein the concavity is designed so that it has the calcar femoral in the area of the lesser trochanter. Other features of the inventive Close the shafts a weird one Edge or rejuvenation on the lateral surface the proximal portion of the shaft in the middle direction, the in combination with the transverse cross-sectional geometry of the proximal Area allows minimal bone removal from the greater trochanter.
  • preferred embodiments The present invention includes the presence of a shaft twist along the longitudinal axis which is most preferably limited to the central shaft region, so that a constant twist angle in the proximal area of the Shaft exists. The isolation of the shaft twist in this area instead of in the proximal area minimizes the enlargement of the implantation sheath, the caused by such a twist while at the same time one improved fit of the implant and stability in the Implantation creates.
  • A preferred embodiment The present invention is also related to a femoral stem an inner distal slot directed to the apex plane is rotated, preferably at about 30 ° to the flexural rigidity of the shaft in both the sagittal plane and the crest plane to diminish.
  • The Previous objects and features of the invention as well as others Objects and Characteristics are more complete, when the following detailed description of the invention together with the attached Drawings is read.
  • III. Short description the drawings
  • 1 and 1A are anterior or middle views of a left femoral shaft.
  • 1B is a transverse cross section of the shaft along the line 1B-1B in FIG 1 ,
  • 2 and 2A are anterior or median views of a fixed model from which the three-dimensional shape of the femoral stem is derived.
  • 2 B is a transverse cross-section of the solid model taken along lines 2B-2B in FIG 2 ,
  • 3 is an anterior view of a left femoral shaft showing various transverse cross sections AA to JJ.
  • AA to JJ are enlarged views of the respective cross sections, which in 3 were taken.
  • 4 and 4A are anterior and medial views of a left femoral shaft showing the medullary and femoral neck segments of the shaft.
  • 4B is a transverse cross-section taken along the line 4B-4B in FIG 4 ,
  • 5 is a posterior view of a left femoral shaft sitting in the femur.
  • 5A is a transverse cross-section of stem / femur taken along lines 5A-5A in FIG 5 ,
  • 6 is a middle view of a left femoral shaft sitting in a femur.
  • 7 is a supervision of the femoral community.
  • 8th is another anterior view of the left femoral shaft.
  • 9 is a bottom view of the femoral stem.
  • 10 is a transverse cross section of the distal portion of the shaft taken along lines 10-10 of FIG 9 ,
  • 11 Figure 11 is a schematic side view of the shaft showing the elliptical configuration of the distal end.
  • IV. Detailed description of the preferred embodiments
  • The present invention is directed to an improved asymmetrical femoral stem for implantation in a proximal femur. More specifically, certain aspects of the invention are directed to a femoral stem that has several key features that provide an optimal balance of the following factors:
    • (a) stability of the implant / bone interface to withstand forces acting on the femoral head;
    • (b) minimal removal of bone during implantation;
    • (c) maximum ease of insertion of the prosthesis into the femur without undersize or misalignment, and
    • (d) minimal enlargement of the "implantation sheath" during insertion of the stem.
  • Referring to the figures, a left femoral stem component ( 10 ) and has a proximal region ( 20 ), a distal area ( 40 ) and a central shaft region ( 30 ) located therebetween, with each area most preferably forming about one third of the total length of the shaft ( 1 ). The total length (H1) of the stem ( 10 ) preferably ranges from about 11.43 cm to about 16.5 cm (4.5 inches to about 6.5 inches) ( 1A ). The shaft further has a longitudinal or distal axis (Z) which coincides with the distal center (FIG. 5 ) in the distal region ( 40 ) corresponds (see 3 and AA to JJ ). Unlike some usual shafts, the pos terior area (P) of the proximal area, as in 1A shown only a slight arc extending generally in the proximal-distal direction, with a relatively large radius (R) as measured from the anterior surface (A), as in FIG 1A which minimizes the potential for enlargement of the femoral cavity at implantation. In addition, the overall design of the implant, discussed in more detail below, allows a greater femoral neck osteotomy, most preferably about 5 mm higher than conventional hip replacement procedures (ie, about 18 now above the lesser trochanter).
  • The inventive shaft may be made from conventional materials, most preferably a cobalt-chromium-molybdenum alloy (VITALLIUM from Howmedica, Inc.). In a preferred embodiment, the finished surface of the implant is satin except for the tapered pin ( 22 ) and between the points 3 and 4 , as in 1 shown (ie, includes the entire distal region and a portion of the central shaft region), both surfaces having a brightly polished finish ( 1 ).
  • Around the explanation To facilitate, the remaining revelation becomes three sections divided. Section I is on the proximal area of the inventive Shaft directed, Section II is on the middle shaft area directed and section III is on the distal portion of the shaft directed. It should also be noted that although the description the invention and the associated Figures are directed to the left femoral component, the present Invention also for a right femoral component is applicable, which is only a mirror image the left component described and shown here.
  • I. Proximal area
  • Referring to the 1 and 1A includes the proximal region ( 20 ) approximately the upper third of the shaft and is preferably covered with a porous coating (discussed in more detail below). The preferred length of the proximal region is about 3.81 cm (about 1.5 inches) (for a shaft having a total length of about 4.5 inches) to about 6.35 cm (about 2 inches) , 5 inches) (for a shaft having a total length of about 16.5 cm (about 6.5 inches)). The proximal region is still in a proximal section ( 23 ) with an upper end part ( 21 ) and a neck ( 22a ), a central section ( 24 ) and a distal section ( 25 ).
  • The inventive shaft was made of a solid model ( 10 ' ), as in the 2 . 2A and 2 B derived, designed to represent the three-dimensional shape of the object that would provide an optimal fit in the femoral cavity.
  • The solid model ( 10 ' ) has a flat upper surface ( 21a ) arranged on the same plane along the longitudinal axis (Z) as the upper surface (FIG. 21 ) of the prosthesis. The shape of the inventive stem ( 10 ) matches the shape of the fixed model ( 10 ' ) below the level of femoral neck osteotomy. The shape of the stem is derived from the solid model by placing all material over the sloped top surface ( 21b ), which corresponds to the femoral neck osteotomy. The prosthesis neck ( 22a ) ( 1 ) is then the inclined surface ( 21b ) and the surface contour is transformed into that of the cut solid model. Additional surface features may be added to the solid model to modify or adjust the flexural rigidity of the distal stem to the presence of a porous coating, as further discussed below.
  • The transverse or transverse cross-sectional shape of the solid model ( 10 ' ) and the shaft ( 10 ) vary continuously from the proximal to the distal end, as in Figs AA to JJ shown representing typical cross sections through the inventive implant. This shape has been derived to contact multiple key surfaces that are critically located in three-dimensional space to maximize implant-femoral bone contact, especially in the greater trochanter where bone removal can be minimized.
  • Specifically, the shape of the solid model in three-dimensional space may be defined by a series of profiles defined by anterior, posterior, lateral, and transverse projections of the surface of the implant. The transversal form of the solid model, as in the 2 B shown was z. Developed by repetitive experiments using prototypes implanted in carcass thighs and cross cut. Specifically shows 2 B the upper end view of a section of the solid model, where the dimension (X) represents the lateral / median width of the section and the dimension (Y) represents the anterior / posterior width of the section. The proximal cross-section has a substantially curved side (L1) which inclines in the anterior direction to form an inclination angle (α 1 ). This "tilt" geometry of the lateral aspect allows a shaft having a maximum medial / lateral width (X) to be implanted into the femur without the need to place the medial wall of the greater trochanter to facilitate insertion of the shaft into the bone for an improved fit in it again to cut. The chamfer of the lateral side (L1) is indicated by a Li never (a) defined with tangential contact with the lateral side at the most lateral point (B), the line (a) being parallel to the sagittal plane. The lateral side (L1) is bevelled anteriorly to have tangential contact with a second line (b) at a second point (C) such that line (a) intersects line (b) forming an acute angle with one Inclination (α 1 ) in between. This angle is about 10 to about 35 degrees in the lateral-medial direction, most preferably about 20 degrees.
  • The cross section in 2 B further includes a substantially domed anterior or anterior side (A1) having a varying radius of curvature laterally displaced. Preferably, the anterior side is formed to have tangential contact with a line (c) at point (D) such that line (c) is parallel to the apex plane and thus perpendicular to line (a). The anterior side is chamfered medially to form a tangential contact with a line (d) over point (E) and perpendicular to line (b) so that the line (d) is at an acute angle (α 2 ) with respect to Line (c) is oriented. Preferably, the angle (α 2 ) is about 10 to about 30 degrees, most preferably about 20 degrees. Typically, the point (E) is located at a distance (X ') lateral to the middle point of the cross-section (I), where X' is equal to 0.30 X (ie 30% of the median / lateral width).
  • The cross section of 2 B Also includes a substantially domed middle side (M1) which is preferably defined between points G and F and has a radius (R2) as well as a middle point I. Also, a substantially non-convex, preferably flat posterior side (P1 ) is present, which is not part of the invention, and a substantially arched posterior / lateral corner ( 27 ) defined between points A and B with a radius (R1).
  • According to the posterior side is concave. Furthermore, in the preferred embodiment, the center of the circle is the posterior / lateral ( 27 ), at the intersection of the upper surface of the fixed model ( 21a ) and the distal longitudinal axis. The radius of the corner (R1) is large enough that a rigid auger can be brought into the intramedullary canal such that the longitudinal axis of the auger and canal coincide without subsequently forming a gap near the posterior / lateral corner. This requires the radius (R1) to be greater than or equal to the diameter of the drive shaft of the rigid auger.
  • The key plane for the seat and stabilization of the shaft in the femur extends from the level of femoral neck osteotomy to the base of the lesser trochanter. The transverse cross-sectional shape of the stem in this area of the bone can be described by a series of lines and arcs, as in FIG 1B shown. The cross-sections taken along this plane along the longitudinal axis are in the configuration equal to the more proximal cross-sections of the solid model shown in FIG 2 B are shown and include a substantially domed front side (A2), a substantially domed central side (M1) defined between points G and F, and a lateral side (L1) which inclines forwardly to define an inclination angle (α 1 ), as in above 2 B described. The posterior / lateral corner ( 27 ) is defined by points A and B and has a radius (R1) slightly larger than that in the more proximal planes (as in FIG 2 B shown) and is preferably larger than the radius (R2) of the middle side (M2).
  • Another particularly useful aspect of the shaft in this area is the inclusion of a small posterior-medial transitional region ( 28 ) extending from the posterior side (P2) at point (H) to the middle radius at point (G). As shown, this transition region ( 28 ) has a larger radius than that defined by the middle side (M2). The transition region may further approach a line (e) which intersects the points H and G and is inclined at an angle (α 3 ) of about 5 to about 15 degrees in the medial / lateral direction (ie, with respect to line f) most preferably about 8 degrees. The latter feature is particularly preferred as it allows the stem to fit the profile of the femur both within the base of the femoral neck and within the midbows. Conversely, the use of a single arch to connect points H and F results in a shaft profile that contacts the cortex wall of the femur at a point within the posterior medial corner. This may result in an area of localized stress concentration and increased risk of femoral fracture.
  • The previous geometry, both in 1B as well as 2 B is shown, in particular the shape of the lateral, middle and anterior sides and the posterior / lateral and posterior / medial corners makes it possible, for. For example, the stem avoids the strong bone in the area of the greater trochanter, thereby minimizing bone removal in this area of the intramedullary canal for improved stability. In addition, the posterior side (P2) encloses a circular cavity or concavity ( 29 ), as in 1B shown. The circular cavity begins generally below the section line AA and goes up to the cross sections EE (as shown in the corresponding figures) and includes this and is formed so that a Retention of the strong bone of the calcar femoral at the level of the lesser trochanter is possible, whereby the insertion of the implant is facilitated as well as the resistance of the femur to a rotational deformation. This further facilitates the implantation of the largest possible prosthesis that can accommodate the medullary cavity, thereby preventing too small sizing, which is the most common cause of implant failure. The preferred depth (D1) of the circular cavity increases from the most proximal portion to the middle portion of the proximal portion and then decreases again. This depth (D1) is in the range of about 0.1 mm (in the proximal ( 23 ) and distal sections ( 25 )) to about 3.0 mm (in the central section ( 24 )).
  • The foregoing transverse configurations also illustrate another preferred aspect of the inventive shaft, in particular two intersecting segments corresponding to the two adjacent geometric bodies: a femoral neck segment (S) and a medullary segment (T) ( 4 and 4A ). In the transversal plane, as in 4B 9, the medullary segment (T) is disposed at an angle (θ) relative to the femoral neck segment, as discussed in detail below. Such an arrangement allows the implant to be in contact with the following areas simultaneously; anterior and posterior at the level of femoral neck osteotomy; anterior and medial on the level of the trochanter minor and anterior, posterior and lateral within the femoral central shaft.
  • Specifically, the femoral neck segment (S) comprises a triangular part ( 21 ) of the proximal portion and extends from the upper end portion to the distal portion (FIG. 25 ) of the proximal region along the central surface (M) of the stem and encloses it. This is best in the 4 and 4A where the hatched area indicates the femoral neck segment (S) and the remaining portion of the stem comprises the medullary segment (T). The femoral neck segment (S) is further formed such that a transverse cross section taken perpendicular to the distal or longitudinal axis (Z) has a portion (hatched area) corresponding to the femoral neck segment (S), which is preferably elongated, most preferably generally elliptical and including a minor axis (S1) that passes through the incision and intersects the anterior (A) and posterior (P) sides. The cut further includes a major axis (X) perpendicular to the minor axis (S1) passing through the medial (M) and lateral (L) sides.
  • The medullary segment (T) is the remaining portion of the proximal region located adjacent the femoral neck segment and extending from a portion of the upper end portion (FIG. 21 ) and the lateral surface (L) and the distal ( 40 ) and middle shaft ( 30 ) Extends and includes the shaft, as in the 4 and 4A shown (not hatched area). The medullary segment (T) is further configured such that a transverse cross-section taken perpendicular to the distal or longitudinal axis (Z) also has a portion similar to that of the femoral neck segment, which includes a minor axis (T1) passing through the medullary segment runs and the front (A) side intersects, and a major axis or major axis (Y) which is perpendicular to the minor axis (T1) and the lateral side (L) intersects. The two segments are further oriented with respect to each other so that the two major axes form an acute angle (θ). Preferably, the angle (θ) is in a range of about 15 to about 50 degrees, most preferably about 32 degrees. As discussed, the inventive stem preferably has a posterior round cavity (FIG. 29 ), which in this embodiment, as in 4B represented, is arranged at the interface between these two segments.
  • The proximal region most preferably includes a lateral surface that tapers sharply toward the center such that the posterior / lateral corner (FIG. 27 ) of the shaft is closer to the longitudinal axis (Z) of the shaft, such. Tie 3 and AA to DD shown, which leads to a minimum mass in this area. Thus, such lateral and posterior / lateral geometry allows for minimal bone removal from the trochanter major during implantation, as well as minimizing enlargement of the implantation sheath during insertion of the shaft. Preferably, the lateral surface tapers at an angle (θ) ** in the range of about 5 degrees to about 14 degrees, most preferably about 8 degrees, such as 2 degrees. In 4 shown.
  • The 5 and 6 show a left femoral component of the present invention sitting in the intramedullary canal of the femur. 5A further demonstrates the ability of the posterior cavity ( 29 ) to fit around the calcar femoral (B '), minimizing its removal.
  • Referring to the 1 . 7 and 8th closes the upper part ( 21 ) of the shaft continue to neck ( 22a ) receiving a modular femoral neck component (not shown) in the preferred embodiment. The neck is inclined at an angle of approximately 2 degrees anteversion in the sagittal plane (ie, anterior / posterior direction). In the apex plane, the neck is disposed at an angle (θ 1 ) with respect to the longitudinal axis (Z) in the range of about 45 to about 55 degrees, more preferably about 48 degrees, as in FIG 1 shown.
  • As in the 7 and 8th shown, the shape of the proximal region is such that the dimensi on (V) of the apex plane (from the middle surface to the lateral surface) is greater than the dimension (U) in the sagittal plane (from the anterior surface to the posterior surface). Such relative dimensions increase the range of motion of the femoral head by about 10 degrees per side, giving a total of 20 degrees in the anterior and posterior directions. [Dimension (V) is preferably in the range of about 2.54 cm to about 5.08 cm (about 1 inch to about 2 inches). The dimension (U) is preferably in a range of about 1.27 cm to about 2.54 cm (about 0.5 inch to about 1 inch)]. A preferred femoral head for use in the present invention is a V-40 head manufactured by Howmedica Inc. which has a taper of 5 ° -40 'in the range of -4 mm offset to +16 mm offset at multiple head diameters , The preceding anterior / posterior and medial / lateral dimensions (U, V) allow the use of the V-40 head as well as similarly constructed heads without requiring an edge.
  • Preferably, the proximal region includes a porous peripheral coating, such as through the shaded portions in the 1 . 3 . 5 . 6 and 8th z. B. shown. This composition and method of applying to the femoral shaft is z. In U.S. Patent No. 4,550,448 (Kenna), which is incorporated herein by reference. The porous coating is designed to promote ingrowth of the bone. which in turn creates a biological seal to prevent the migration of particulate debris.
  • II. Middle shaft area
  • It is recognized in the art that creating a twist in the shaft it allows that The shaft of the shape of the femoral cavity easier during the Implantation adapts. Certain usual Femoralschäfte have a twist that in the proximal region or substantially along the entire length of the shaft occurs. A disadvantage, if a twist in the proximal Area of the prosthesis, it is that at implantation the axial rotation of the shaft, which occurs due to the rotation, to enlarge the anterior and posterior walls of the femoral cavity and subsequent formation of gaps between the shaft and bone contributes. In a preferred embodiment The present invention alleviates this problem by: the rotation of the central shaft portion of the shaft is restricted, where a tight cattle seat is not common. This allows, that the shaft enters the femoral canal with minimal rotation during the last stages of insertion is used.
  • As in the 1 and 3 z. B. shown, the middle shaft area ( 30 ) of the hip stem generally the area between the cross-sectional lines FF and JJ. Preferably, the length of the central shaft ranges from about 5.08 cm (about 2 inches) (for a smaller shaft) to about 6.35 cm (about 2.5 inches) (for a larger shaft). In the present invention, the stem has a twist that extends beyond the middle stem region, generally beginning at the distal border (FIG. 6 ) of the central shaft region (ie on the cross-sectional line JJ), extends in the proximal direction and at the proximal border ( 7 ) of the central shaft portion ends (ie, at the cross-sectional line FF), providing a constant twist angle (t) at the proximal limit with respect to the distal limit, which is consistent over the entire proximal portion of the shaft. The twisting of the shaft is best in 3 and the AA to JJ shown. As shown, the cross sections AA to JJ were taken perpendicular to the longitudinal axis (Z) of the shaft. Line ( 1 ) is from the distal center ( 5 ) to the center of each cross section. Proceeding from the distal end, starting at the intersection JJ to the proximal region, the shaft twists along the longitudinal axis (Z) of the shaft such that the midpoint shifts anteriorly. The broken line ( 2 ) represents the original line from the distal center ( 5 ) to the midpoint of the distal region ( 40 ). Thus, the cross sections are distal to the section JJ, line ( 1 ) and line ( 2 ) identical. Twisting of the shaft continues in the proximal direction and is represented in the remaining cross sections JJ to FF, where the angle (t) between the original line ( 2 ) and the line ( 1 ) represents the twist angle for this cross section. Preferably, the angle (t) of twist over the central shaft region is in a range of about 0.50 degrees to about 8 degrees, most preferably about 3 to about 5 degrees. In a preferred embodiment, for. Example, the angle (t) in cross section JJ about 1 degree, in cross section II about 1.75 degrees, in cross section HH 2.75 degrees, in cross section GG about 3.5 degrees and in cross section FF about 4 degrees. The actual rotation ends at the proximal boundary, so that the angle (t) at the cross sections AA to EE (ie the proximal region) is constant z. 4 degrees, based on the distal limit.
  • III. Distal area
  • The distal area ( 40 ) of the stem most preferably has a length in the range of about 3.05 cm to about 5.08 cm (about 1.2 to about 2 inches). Referring to the 8th to 10 the shaft ( 10 ) according to a further preferred embodiment of the invention, an inner slot ( 41 ) extending longitudinally through the distal end and along the distal (ie, longitudinal) axis (Z) to reduce bending stiffness. Different as in the conventional "straight slot" design where the flexure is reduced only in the apex plane, the present invention allows for a further reduction in flexural stiffness in both the sagittal and apex planes, thereby providing more flexibility with respect to distal peak loads while walking and climbing stairs. Specifically, the shaft has a distal inner slot ( 41 ) which is rotated at an acute angle (b) to the apex plane in order to cut the distal end into two separate points or prongs, preferably a posterior / medial tip (FIG. 44a ) and an anterior / lateral tip ( 44b ), such. Tie 8th to 10 shown. This angle (b) is defined by the intersection between an axis ( 42 ) lying in the apex plane and an axis ( 43 ) located centrally within the slot ( 41 ) is arranged. Preferably, the angle of rotation (b) is in a range of about 15 degrees to about 60 degrees, most preferably about 30 degrees. The length (L4) of the slot is in a range of about 0.50 inches to about 2 inches, most preferably about 1 inch.
  • The distal area ( 40 ) continues to close a distal end ( 40a ), which preferably tapers elliptically, such as. Tie 8th and 11 shown. This construction of the distal end acts to distribute stress exerted on the femur over a larger area and further decrease the voltage magnitude at each particular location. The elliptical configuration includes a half-size diameter (d1), which is preferably about three times the length of the half-smaller diameter (d2).
  • The previous slot ( 41 ) is most preferably used with sheaths having a distal diameter greater than 11 mm (ie, about 0.43 inches). Preferably, the width (W) of the slot is about 0.23 cm to about 0.43 cm (about 0.09 inches to about 0.170 inches), most preferably about 0.32 cm (about 0.125 inches).
  • The distal region may further comprise a depression ( 45 ) on the outer surface of one or more tips, most preferably both, to reduce the rigidity of the implant. As in 10 illustrated, the indentation ( 45 ) has a radius (R4) in the range of 0.25 cm to about 0.33 cm (0.1 to about 0.13 inches). The two radii (R5) of the remaining part of each peak (R5) 44a . 44b ) have a size in the range of about 0.25 cm to about 0.36 cm (about 0.10 inches to about 0.14 inches).

Claims (15)

  1. Femoral hip stem for a prosthesis having posterior (P), anterior (A), middle (M) and lateral (L) surfaces, the stem further comprising: (a) a distal region (Fig. 40 ) having a distal portion, a center and a longitudinal axis (Z) intersecting the center, the axis (Z) further defining anterior, posterior, medial and lateral surfaces; (b) a proximal region ( 20 ) and (c) a central shaft region ( 30 ) between the distal and proximal areas ( 40 . 20 ) is arranged; wherein at least one cross section perpendicular to the longitudinal axis (Z) through the proximal region ( 20 ): (d) a substantially curved anterior side (A1) of varying radius of curvature; (e) a posterior side (P1) with a concavity (P1) 29 ); (f) a substantially curved middle side (M1); (g) a substantially curved lateral side (L1); characterized in that (h) the lateral side (L1) is inclined anteriorly to form an acute angle of inclination (α 1 ) in the range of about 10 to about 30 degrees, the angle of inclination (α 1 ) being defined by a straight line (a) having tangential contact to the lateral side (L1) at the most lateral point (B) and parallel to the sagittal plane, and a straight line (b) extending through the most lateral point (B) to the lateral side (B) L1) and has tangential contact with the lateral side (L1) at a second point (C) anterior at a distance from point (B) so that line (a) intersects line (b) at point (B) to form the acute inclination angle (α 1 ) therebetween.
  2. Shaft according to claim 1, wherein the posterior concavity ( 29 ) has a depth (D1) of about 0.1 to about 3.0 mm.
  3. Shaft according to claim 1, wherein the cross-section further comprises a substantially curved posterior / lateral corner ( 27 ) having a radius of curvature (R1) greater than the radius of curvature (R2) of the center side (M1).
  4. Shaft according to claim 1, wherein the cross section further comprises a transition region ( 28 ) connecting the posterior and medial sides (P1, M1), the transition region ( 28 ) has a radius of curvature greater than the radius of curvature (R2) of the central side (M1).
  5. The shaft of claim 1, wherein the shaft further has a rotation about the distal axis (Z).
  6. Shaft according to claim 5, wherein the twist is generally at the distal border (G) of the central shaft region (FIG. 30 ) and at the proximal border ( 7 ) of the middle shaft region ( 30 ) ends.
  7. Shaft according to claim 6, wherein the twist in the middle shaft area ( 30 ) is about 0.50 to about 8 degrees.
  8. Shaft according to claim 1, wherein the distal region ( 40 ) further comprises an inner slot ( 41 ) which extends longitudinally beyond the distal end and along the distal axis (Z).
  9. Shaft according to claim 8, wherein a cross section of the distal region ( 40 ) taken perpendicular to the distal axis (Z) has a first axis ( 42 ) extending through this section in the medial / lateral direction and a second axis ( 43 ) located centrally within the slot ( 41 ) and perpendicular to the distal axis (Z); wherein the first and second axes ( 42 . 43 ) define an acute angle (b) in the distal center that covers the distal region (FIG. 40 ) into two separate tips ( 44a . 44b ) Splits.
  10. The femoral hip stem for a prosthesis according to claim 1, further comprising a distal axis (Z) defining posterior (P), anterior (A), middle (M) and lateral (L) surfaces, the stem further comprising: a ) a femoral neck segment (S) having a portion of a proximal region (Fig. 20 ) of the shaft, the part enclosing the central surface (M) and b) a medullary segment (T) adjacent to the femoral neck segment (S) in the proximal region (Fig. 20 ) extending from an upper end portion ( 21 ) of the proximal region ( 20 ) and the lateral surface (L) of the shaft and encloses this, wherein the medullary segment (T) further comprises a central shaft region ( 30 ) below the proximal region ( 20 ) and a distal area ( 40 ) under the middle shaft region ( 30 ) includes; the proximal region ( 20 ) of the stem is further formed so that a cross section taken perpendicular to the distal axis (Z) comprises: c) a portion corresponding to the femoral neck segment (S) having a minor axis (S1) passing through the femoral portion and the front surface (A) extends and a major axis (X) perpendicular to the minor axis (S 1) passing through the central area (M) and d) a portion corresponding to the medial segment (T) having a minor axis (T1) passing through the medullary portion and the front surface (A) and a major axis (Y) perpendicular to the minor axis (T1) passing through the side surface (L); the medullary axis (Y) and the femoral main axis (X) being oriented towards each other so as to form an acute angle (θ).
  11. The shank of claim 10, wherein the angle (θ) is about 20 to about 35 degrees is measured in anterior-posterior direction.
  12. Shaft according to claim 10, wherein the posterior concavity ( 29 ) is disposed on the posterior surface (P1) along a junction between medullary and femoral neck segments (T, S).
  13. The shaft of claim 10, wherein the shaft further having a twist about the distal axis (Z) of the shaft.
  14. The shaft of claim 13, wherein the twist is generally at a distal limit ( 6 ) of the middle stem region ( 30 ) and at a proximal border ( 7 ) of the middle stem region ( 30 ) ends.
  15. Shaft according to claim 14, wherein the rotation in the central shaft region ( 30 ) is about 0.50 to about 8.0 degrees.
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AU719572B2 (en) 2000-05-11
CA2205727C (en) 2002-06-11
US6102957A (en) 2000-08-15
US6007581A (en) 1999-12-28
US5776204A (en) 1998-07-07
EP0808618B1 (en) 2005-03-09
AT290354T (en) 2005-03-15
JPH1043218A (en) 1998-02-17
CA2205727A1 (en) 1997-11-24
EP0808618A3 (en) 1999-03-10
EP0808618A2 (en) 1997-11-26
DE69732677D1 (en) 2005-04-14
AU2360697A (en) 1997-11-27
JP3346530B2 (en) 2002-11-18

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